Qualification and classification of medical devices

This webpage provides information for manufacturers on how to qualify their products as medical devices. It also covers the application of MDR classification rules. 

It is the responsibility of manufacturers to correctly qualify and classify their products.

Qualification of medical devices

In order for a product to qualify as a medical device, it must meet the definition outlined under Article 2(1) of the Medical Devices Regulation (MDR).

A medical device must have a medical purpose. It must also act primarily by physical means and not by pharmacological, immunological or metabolic means.

Software may also meet the definition of a medical device. The Medical Device Coordination Group (MDCG) has published guidance on the qualification and classification of software under the MDR and the IVDR. This document defines the key criteria for correctly qualifying software as a device for manufacturers.

Classification of medical devices

The MDR categorises medical devices into four risk classes based on their risk;

  • Class I (lowest risk),

  • Class IIa,

  • Class IIb and

  • Class III (highest risk).

The risk class of a device will determine its performance and safety requirements as well as its route to market. Devices must be correctly classified using MDR classification rules. Annex VIII of the MDR outlines these rules.

Once a device is correctly classified, it must undergo its applicable conformity assessment procedure in order for it to be CE marked and placed on the EU market.

The MDCG has published guidance on the classification of medical devices. This document provides practical information for manufacturers on the purpose and relevance of device classification. It also covers the application of MDR classification rules.

Borderline products

In some cases, it may be difficult to correctly qualify or classify products. In these cases, we encourage manufacturers to review the Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices. This document serves as a tool for the case-by-case application of community law.

The MDCG has also published specific guidance on the qualification of borderline medical devices and medicinal products.